C&Q Lead: Pharma Commissioning & Qualification Leader

FITS LLC; Vilafranca del Penedès; On-site; EUR 70,000 - 90,000; Full time

Job summary

FITS LLC in Spain seeks a CQV support professional for the Global Engineering area. The role requires 7+ years in commissioning, qualification, validation, and related disciplines within regulated industries.

Bilingual Spanish and English, with strong communication, organization, and problem-solving skills, is essential. You will lead day-to-day C&Q activities, coordinate engineers, contractors, and vendors, and support plans, schedules, and documentation to meet project milestones while

Qualifications

• Bachelor’s degree required in Life Science or Engineering.
• 7+ years of experience in commissioning, qualification, validation.
• Experience in pharmaceutical, biotech, medical device, or regulated industries.
• Strong communication and problem-solving skills.
• Bilingual Spanish & English.

Responsibilities

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered on milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, and readiness activities.
• Ensure all activities comply with health, safety, environmental, quality, and GMP requirements.

Skills

Bilingual Spanish & English

C&Q coordination

Contractor/vendor coordination

Regulated industry experience

Multi-priority management

Risk-based commissioning

Education

Bachelor’s Degree in Life Science or Engineering

Job description

FITS LLC in Spain seeks a CQV support professional for the Global Engineering area. The role requires 7+ years in commissioning, qualification, validation, and related disciplines within regulated industries.

Bilingual Spanish and English, with strong communication, organization, and problem-solving skills, is essential. You will lead day-to-day C&Q activities, coordinate engineers, contractors, and vendors, and support plans, schedules, and documentation to meet project milestones while